Trends in adverse events and related health-care facility utilization from cough and cold medication exposures in children

Abstract

Introduction

Initial research following regulatory changes addressing the pediatric safety of cough and cold medications (CCMs) demonstrated decreases in adverse events (AEs). Using a national multi-source surveillance system, we studied subsequent CCM-related AE case rate trends and associated health-care facility (HCF) evaluation in children.

Methods

Data were collected from 2009 to 2016. Case eligibility included: age <12 years; exposure to an over-the-counter product containing ≥1 CCM pharmaceutical ingredient; ≥1 significant AE that occurred in the United States.

Results

About 4756 (72.6%) cases were determined at least potentially related to an index ingredient. Accidental unsupervised ingestions (AUIs; 3134; 65.9%) were the most common case type. Nearly half of AE cases involved children 2 to <4 years old (2,159; 45.4%). The AE case rate did not change significantly over time (p = 0.22). The proportion of AE cases resulting in HCF admission increased from 32.4% (207) in 2009 to 43.4% (238) in 2016 (p < 0.01). Exposures to diphenhydramine (1,305; 67.3%) and/or dextromethorphan (591; 30.5%) were involved in the majority of HCF admissions.

Conclusions

The proportion of AE cases resulting in HCF admission increased from 2009 to 2016. Efforts to prevent AUIs such as packaging innovation and engineering controls, particularly for diphenhydramine and dextromethorphan-containing products, should be pursued.

Keywords:

• Pediatric safety surveillance
• cough/cold medication safety
• trends
• sales-adjusted rates
• medication safety

Acknowledgments

The authors acknowledge Heather Delva-Clark for her many years of project management and case abstraction.

Disclosure statement

The sponsor had no involvement in the conduct of the study or decision making including as it relates to the development of this manuscript. JG, KR, MO, GW, and RD were employees of Denver Health at the time the work was performed. Outside the submitted work, JG, KR, MO, and RD report grants from Johnson and Johnson Consumer Inc. SW receives royalties from UpToDate® for authorship contributions, all outside the submitted work. IP reports personal fees from Johnson & Johnson, and Pfizer, all outside the submitted work. All other authors report no financial relationships relevant to this article to disclose.

Financial disclosure

JG, RD, KR, and MRO report grants from Consumer Healthcare Products Association Pediatric Cough Cold Task Group, during the conduct of the study and grants from McNeil Consumer Healthcare, outside the submitted work. SW receives royalties from UpToDate® for authorship contributions, all outside the submitted work. IP reports personal fees from Johnson & Johnson, and Pfizer, all outside the submitted work. All other authors report no financial relationships relevant to this article to disclose.

Data availability statement

These data are owned by the Consumer Healthcare Products Association and requests for access should be made directly through that organization.

Additional information

Funding

This study was funded through an unrestricted grant provided by the Consumer Healthcare Products Association Pediatric Cough Cold Task Group to Denver Health’s Rocky Mountain Poison and Drug Safety.